Earlier this week, New York Governor David Paterson announced that his administration would propose new, tougher prohibitions on pharmaceutical, biotech and medical device companies (medical manufacturing companies), restricting them from dispensing gifts and misleading production information to doctors while promoting the use of specific drugs.
Below is a summary of the proposed changes:
The bill attempts to “ensure that the relationship between medical manufacturing companies and health care professionals does not interfere with the independent judgment of such professionals in making prescribing decisions."
The bill would require companies to have a written contract specifying the nature of the consulting services to be provided and the basis for payment of those services. Companies and professionals would also have to demonstrate a “legitimate need” for the services.
Health care professionals would also have to maintain records about the use of consulting services. This section would also require meetings for consultants to be held in a “conducive” venue.
The New York legislation states that medical manufacturing companies will be prohibited from providing a health care professional “any financial support, including but not limited to any grant, scholarship, subsidy, support, consulting contract, speaker contract or educational or practice-related items to reward the professional for having prescribed particular drugs, biologics or medical devices in the past, or to induce the professional to prescribe or continue prescribing particular drugs, biologics or medical devices in the future.” This prohibition does not include compensation for bona fide consulting services or speaker services.
The bill would not prohibit medical manufacturing companies from giving health care professionals rebates or discounts. The bill would still allow “the investment of a medical manufacturing company in a business venture in the medical manufacturing or biotechnology field in which a health care professional is a principal, or other joint arrangement between a medical manufacturing company or health care professional in such a venture, provided that the relationship between the company and the professional chiefly relates to such venture and is not intended to influence the professional's prescribing decisions.”
With regards to promotional materials, the bill states that “medical manufacturing companies are prohibited from providing any promotional materials to a health care professional unless such materials:
(a) are accurate and not misleading;
(b) make claims about a product only when properly substantiated;
(c) accurately reflect the balance between risks and benefits;
(d) are consistent with all other requirements of the united states food and drug administration governing such communications; and
(e) do not violate the provisions of article twenty-two-a of the general business law.
Medical manufacturing companies would also be prohibited from providing meals to health care professionals and staff unless such meals:
(i) are provided in connection with structured, oral informational presentations that provide scientific or educational value;
(ii) are served only for consumption during such presentation and are not offered or served at another time or place or outside the presence of the medical manufacturing company;
(iii) are, provided only in the professional's office or in a hospital setting; are “modest;”
(iv) are not offered or provided to spouses or other guests of a health care professional;
(v) are not part of an entertainment or recreational event; are on no more than an occasional basis; and are “conducive to informational communication.
Outside of the professional’s office or hospital settings, medical manufacturing companies can provide health care professionals meals if they are incidental; are not part of entertainment or a recreational event; are conducive to informational communication and training about medical information; are modest; and are on an occasional basis.
In addition, medical manufacturing companies cannot offer health care professionals, and no health care professional can accept any entertainment or recreational items. This section does not apply to health care professionals employed by the medical manufacturing company on a full-time, salaried basis.
Continuing Medical Education
Concerning continuing medical education (CME), the bill states that “no medical manufacturing company shall be a provider of any CME program within the state.” Moreover, the legislation states that no medical manufacturing company shall be a sponsor of any continuing medical education program within the state unless the company has adopted and is in compliance with policies by which the company:
(i) has separated its continuing medical education grant-making functions from its sales and marketing departments and does not permit its sales and marketing departments to have any involvement in its continuing medical education grant-making activities;
(ii) has developed and utilizes objective criteria for making continuing medical education grant decisions to ensure that the program funded by the company is a bona fide educational program and that the financial support is not an inducement to prescribe or recommend a particular medicine or course of treatment; and
(iii) agrees to respect the independent judgment of the continuing medical education provider and to follow standards for commercial support established by the accreditation council for continuing medical education.
Medical manufacturing companies are also prohibited from:
– Providing any advice or guidance to the CME provider, regarding the content or faculty for a particular CME program funded by the company; and
– Providing any verbal or written information to a health care professional who is expected to serve as a presenter at such CME program regarding any drug, biologic or device manufactured, distributed or marketed by or on behalf of the company.
– Providing any financial support in connection with the professional's attendance or presentation at a CME program, including time spent attending or presenting at the CME program or to reimburse the professional for the costs of travel, lodging, or other personal expenses incurred for attendance or presentation at the continuing medical education program.
– A full-time salaried employee of a medical manufacturing company, or who is engaged by the company as a speaker or consultant for a CME program can receive financial support for time and travel expenses.
This is already the case for CME programs under the ACCME accreditation system and similar systems.
Especially cumbersome is the proposed rule that no health care professional practicing in the state shall attend or present at any continuing medical education program sponsored by any pharmaceutical company unless advised by the program provider that such medical manufacturer has provided assurance that it has adopted the policies stated above. This will require some type of certifications for every company that exhibits at your meeting regardless of the size of the exhibit or amount of contribution.
The bill states however, that a CME provider can use its own discretion to apply financial support received from a medical manufacturing company to reduce the overall CME registration fee for all attendees. Medical manufacturing companies however cannot provide meals directly at CME programs, except that a CME provider at its own discretion may apply the financial support provided by a company for a CME program to provide modest meals for all participants.
Health care professionals who present at CME programs:
– May not represent that he or she authored any materials discussed, distributed or otherwise presented during his or her presentation at such unless he or she made “substantial contributions” to the intellectual content of such materials.
– Presenters must also disclose during their presentation the existence and nature of any financial support he or she has received from or expects to receive from a sponsor of such continuing medical education program or from a medical manufacturing company that medical manufacturing , distributes or markets any drug, biologic or medical device discussed in such presentation or commonly prescribed for a disease, injury or condition discussed in such presentation.
FDA Regulated Education
FDA regulated conference or meetings also have similar restrictions as CME programs regarding medical manufacturing company financial support.
Medical manufacturing companies who retain a health care professional as a speaker:
– Are required to place caps on the total amount of annual compensation it will pay to an individual health care professional in connection with all speaking arrangements at a reasonable amount.
– Have to provide periodic monitoring of speaker programs for compliance FDA requirements for communications on behalf of the company about its medicines.
– Companies must also have each speaker clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.
Speakers or consultants who are a member of a committee that sets formularies or develops clinical guidelines are prohibited from speaking or consulting unless the company requires that the professional disclose to such committee the existence and nature of his or her relationship with the company, for as long as such relationship lasts and for at least two years after such relationship is terminated.
Medical manufacturing companies are also prohibited from providing financial assistance for scholarships or other educational funds to permit medical students, residents, fellows, and other health care professionals in training to attend educational conferences unless: (a) such conferences are sponsored by the major educational, scientific, or policy-making meetings of national, regional, or specialty medical associations; and (b) the selection of individuals who will receive the assistance is made by the academic or training institution.
With regards to gifts, medical manufacturing companies cannot provide to health care professionals or members of their staff floral arrangements, artwork, compact discs or tickets to a sporting event, pens, note pads, or mugs, except for educational items.
In relation to health care professionals items designed primarily for the education of patients or health care professionals, medical manufacturing companies are allowed to provide such items as long as they are not of substantial value, and are not offered on more than an occasional basis.
Penalties for a medical manufacturing company for breaking any section in the proposed bill are a minimum of $15,000 and a maximum of $250,000 per violation. Individual health care professionals who violate any section of the proposed legislation are penalized not less than $5,000 and not more than $20,000 per violation.
Many of the rulings are already in place under the PhRMA Code. This would however add new restrictions on freedom of assembly (attendance at meetings..). The proposal calls for an end of outside funding for fellows programs (which is a valuable service that companies provide to Universities).
Overall this is one of the most restrictive proposals for physician education. By adding additional restrictions to education it will limit information sources of physicians and in the end hurt patients. With Paterson’s popularity at an all time low it is likely this proposal is dead on arrival. But it does give us insight as to the next generation of restrictive measures proposed in states.
Physicians and organizations who collaborate with medical manufacturing companies in New York should express outrage at such proposals.